Clinical Research Training Requirements

IMARC Research’s new whitepaper examines the similarities and differences between the current US regulations and places them within the context of any number of roles found within the realm of clinical research. While there are no direct references within the regulations as to what types and to what degree training is required, a well-developed training curriculum is a prerequisite for quality research.

Training is now recognized as an essential requirement needed to conduct well-controlled clinical trials that result in protected patients and data integrity, and more resources are available than were previously. There are multiple professional organizations devoted to the clinical research industry and committed to providing their members with the most current information through trainings, journals, and conferences. These organizations promote certification in role-based categories designed for CRAs, CRCs, and Investigators and require continuing education to maintain those certifications. Universities are now offering degrees or certificates in Clinical Research Administration, Clinical Monitoring, or other clinical-research related majors. Continuing education is available through in-person or web-based training for employers and ambitious professionals. And sponsors and CROs are providing more robust site initiation visit trainings to include topics such as investigator responsibilities, ethical considerations, good clinical practice, and inspection preparedness, to name a few.

Even through the best efforts of sponsors and contract research organizations to train investigators on GCP standards, according to annual BIMO findings, there is clearly still room for improvement. Participating in clinical research, no matter what your role, requires an understanding of the regulations, industry standards, and best practices. Different roles will require tailored training to ensure employees are qualified for their responsibilities.